ARVIS ®

GUDID 00850012315254

ARVIS Computer Module

Insight Medical Systems, Inc.

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• Primary Device ID: 00850012315254
• NIH Device Record Key: 4942b3a9-e5e9-47c9-beed-024fe011d243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARVIS ®
• Version Model Number: 12700
• Company DUNS: 080536842
• Company Name: Insight Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012315254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203115

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-12

On-Brand Devices [ARVIS ®]

• 00850012315384: Femoral Slot Adapter, Parallel
• 00850012315377: Charger, 25W USB-C, USA
• 00850012315360: Landmark Punch
• 00850012315353: Adapter, DJO Impactor
• 00850012315346: Femoral Reference Mount, Right
• 00850012315339: Femoral Reference Mount, Left
• 00850012315322: Distal Guide Tracker
• 00850012315315: ARVIS Hip and Knee Instrument Set, Packaged
• 00850012315308: ARVIS Surgical Navigation System
• 00850012315292: ARVIS Charger Cord, USA
• 00850012315285: ARVIS Charger Power Supply
• 00850012315278: ARVIS Battery Charger
• 00850012315261: ARVIS Battery
• 00850012315254: ARVIS Computer Module
• 00850012315247: ARVIS Eyepiece Cable
• 00850012315230: ARVIS Belt Pack
• 00850012315223: ARVIS Eyepiece
• 00850012315216: Femoral Reference Mount
• 00850012315209: Tracker C
• 00850012315193: Tracker A
• 00850012315186: Distal Guide
• 00850012315179: Adjustable Cutting Block
• 00850012315162: Tibial Reference Mount, Right
• 00850012315155: Tibial Reference Mount, Left
• 00850012315148: Tibial Slot Adapter
• 00850012315131: Femoral Slot Adapter
• 00850012315124: 2.5mm Ball Driver
• 00850012315117: 3.5mm Hex Driver
• 00850012315100: Tracker B
• 00850012315094: Impactor V-Block Assembly
• 00850012315087: Tracker D
• 00850012315070: Reference Tracker 1
• 00850012315063: Reference Mount
• 00850012315056: Registration Stylus
• 00850012315049: Pin Caddy Lid
• 00850012315032: Pin Caddy
• 00850012315025: ARVIS Hip and Knee Instrument Set
• 00850012315018: Instrument Tray Lid
• 00850012315001: Instrument Tray Base
• 00850012315551: Pin Caddy Lid
• 00850012315544: Pin Caddy
• 00850012315537: ARVIS Hip and Knee Instrument Set
• 00850012315520: Instrument Tray Base
• 00850012315513: Registration Stylus
• 00850012315506: Tracker A
• 00850012315490: Impactor Adapter, DJO
• 00850012315483: Tibial Reference Mount, Right
• 00850012315476: Tibial Reference Mount, Left
• 00850012315469: Adjustable Distal Guide
• 00850012315452: Femoral Cutting Block